US 12,186,281 B2
Oral solid cannabinoid oil composition for treating gastrointestinal disorders
Syed M. Shah, Boca Raton, FL (US); and Fred Hassan, Boca Raton, FL (US)
Assigned to Societe des Produits Nestle S.A., Vevey (CH)
Appl. No. 17/758,315
Filed by SOCIETE DES PRODUITS NESTLE S.A., Vevey (CH)
PCT Filed Jan. 8, 2021, PCT No. PCT/EP2021/050245
§ 371(c)(1), (2) Date Jul. 1, 2022,
PCT Pub. No. WO2021/140183, PCT Pub. Date Jul. 15, 2021.
Claims priority of provisional application 62/958,392, filed on Jan. 8, 2020.
Prior Publication US 2023/0065736 A1, Mar. 2, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/05 (2006.01); A61K 9/16 (2006.01); A61K 9/50 (2006.01)
CPC A61K 31/05 (2013.01) [A61K 9/1652 (2013.01); A61K 9/1694 (2013.01); A61K 9/5073 (2013.01)] 17 Claims
OG exemplary drawing
 
1. A method for preparing an oral pharmaceutical dosage form, the method comprising:
wet granulating microcrystalline cellulose and a cannabinoid oil together forming a solid matrix in which the cannabinoid oil is bound in the microcrystalline cellulose; and
combining the solid matrix with at least one pharmaceutical excipient to form the oral pharmaceutical dosage form,
the oral pharmaceutical dosage form comprising a plurality of individual particulates, wherein the individual particulates are spheroidal and comprise:
(a) a solid core including an effective amount of the cannabinoid oil bound in the microcrystalline cellulose (MCC) in a ratio of the cannabinoid oil to the MCC of 0.5:1 to 1.5:1; and
(b) an enteric coating over the solid core,
wherein the individual particulates are selected from the group consisting of:
(i) the individual particulates have an average diameter of 0.5 mm to 1.7 mm and further comprise an enteric coating material and a disintegrant combination configured for the individual particulates to release at least about 50% of the cannabinoid oil in a subject's duodenum for treating inflammation of the duodenum;
(ii) the individual particulates have an average diameter of 0.5 to 1.7 mm and are configured to release at least about 50% of the cannabinoid oil in a subject's jejunum for treating inflammation of the jejunum; and
(iii) the individual particulates have an average diameter of 0.5 to 1.7 mm and are configured to release at least about 50% of the cannabinoid oil in a subject's ileum for treating inflammation of the ileum,
wherein the individual particulates comprise 10% w/w to 50% w/w of the cannabinoid oil, 40% w/w to 75% w/w of the microcrystalline cellulose, 2% w/w to 10% w/w methyl cellulose, and 2% w/w to 35% w/w of the enteric coating.